The Senior Manager, Technical Operations will provide phase appropriate CMC GMP support for Odonate’s drug candidates. This position will serve as a CMC/Technical Operations representative for selected programs. This position will support the transition of internally developed manufacturing processes to contract manufacturing partners inclusive of scale up and process validation at contract manufacturing sites.
Essential Duties and Responsibilities
Work closely and collaboratively with Odonate’s internal development team and external drug product related manufacturing partners to define, optimize and scale GMP manufacturing processes
Collaborate and approve CMO master batch records, perform CMC review of executed of batch records for drug product and packaging/labeling
Work with CMC stability and analytical to assure drug product release test and stability programs are in place to support IND and NDA filings
Author and review technical reports, SOPs, validation protocols and regulatory sections of cGMP related documents
Qualifications
Bachelor’s Degree in Chemistry or related science required
Minimum 5 years of progressive experience working in a cGMP pharmaceutical environment required
Experience working with third-party formulation development, drug product manufacturing and clinical/commercial packaging vendors
Must have experience with CMC writing and competent regulatory filing requirements
Knowledge of analytical method validation and manufacturing process validation
Previous experience in drug product formulation of tablets and capsules
Experience with small molecule product development preferred
Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
Must be willing and able to travel domestically and/or internationally up to 20%